Polarion ALM User Experiences in Medical Device Industry

Planmeca Oy is the largest privately owned dental manufacturing company in the world. The group’s turnover in 2016 was MEUR 730, employing nearly 2,700 people worldwide. The company has used Polarion ALM solution since 2013.

To share a professional insight about the use of Polarion ALM (Application Lifecycle Management) in medical device industry we interviewed Process Development Manager Veijo Inkiläinen, Product Development Manager Sakari Kettunen and Product Development Manager Helka Ojanperä from Planmeca Oy.

 

Six Questions about Polarion ALM

 

1. Why did Planmeca choose Polarion ALM Solution?

Sakari Kettunen: “Polarion includes all features essential in the medical device industry including electronic signatures, DHF (Design History File) and automated traceability matrix. These features make traceability easy and minimize manual work.”

Veijo Inkiläinen: “For our industry Polarion is an essential tool since it adapts to different processes. Other tools may be good in some niche areas like test management or project management but Polarion can be used for everything. With Polarion there is no need to change the company’s existing processes, if we don’t want to.”

 

2. What kind of benefits have you experienced?

Veijo Inkiläinen: “Polarion helps to speed up our processes and satisfy the regulatory requirements by providing end to end traceability between requirements, design and verification. In the field of medical devices this is a substantial advantage, because we need to make sure that we have fulfilled all safety and essential requirements in our products. At first we used Polarion for CAPA (Corrective and Preventive Action) process. Polarion proved to be a cost-efficient solution. Using Polarion soon spread to software development, requirements management and risk management.”

Helka Ojanperä: “Traceability between information artifacts is a major requirement in the healthcare industry. Polarion enables us to create a clear process all the way from requirements to test cases.”

Sakari Kettunen: “The requirements management and change management of software development are now in one system which is more efficient. For example, in a software release with 30 changes all those can be listed automatically from the database to a Polarion document and then approved and signed electronically. The old way was to fetch data from another system to Excel, then to Word, then print it and get the paper signed. It is obvious why Polarion is a superior solution here.”

 

3. Does Polarion speed up agile development processes?

Veijo Inkiläinen: “Indeed, Polarion has done that. We are saving a lot of time as we don’t have to look for information from several sources and we can be sure that all planned artifacts are done. In Polarion all relevant information is easy to keep up to date.”

Sakari Kettunen: “In software development manual work has decreased remarkably. With Polarion it is fast to monitor all implemented changes and even see in which code module they are located. This was a big challenge earlier on. We use Polarion as a tool for agile software development – from iteration to project management.”

 

4. Was validating Polarion as a storage for medical device quality data difficult?

Veijo Inkiläinen: “In the medical device industry the use of electronic archives is a challenge since the industry has precise instructions and regulations on which features the archive should contain. Planmeca has validated Polarion as an electronic archive, which actually was not a lengthy project at all. A big help was that Polarion has existing certificates to prove it is a valid solution conforming to state-of-the-art standards.”

 

5. How would you assess different features of Polarion?

Veijo Inkiläinen: “Polarion is easy to adapt to requirements management and risk management. Other areas function great as well. Test management is simple but it does everything that we have a need for.”

 

6. What advice would you give to a company starting to use Polarion?

Sakari Kettunen: “Polarion is a versatile tool for requirements and risk management as well as verification and validation. Creation of the needed documentation is easy as well. Because of its versatility, it is important to have a common model in the organization how to work with it.”

Veijo Inkiläinen: “Proper training to use of the tool is essential. Taipuva gave us great training in the beginning. I recommend to

  1. Pilot the use of Polarion in some smaller projects first.
  2. Define the model of artifacts and linking hierarchy between them early.
  3. Modify the model based on the feedback gathered in pilot projects.
  4. Standardize and deploy it to other projects.”

 

 

What is Polarion ALM?

It’s a Siemens’s Application Lifecycle Management software tool for managing product and software development processes and information pictured below.
– Groundbreaking innovation: LiveDoc combines intuive document and database objects
– 100 % web client – simple one server installation or cloud
– Fast to take into use – Taipuva provides a ready-to-go medical template

For  an introduction see the video below (1 min 37 s)

 

Would this be useful for you?

Let’s have a 1-hour online demo to find out!
Just send us your email address and we’ll get back to you.

 

Taipuva Consulting is a Siemens PLM partner and the official reseller of Polarion ALM in Sweden, Denmark and Finland.

 

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